MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0 TI LOCKING SCREW SELF-DRILLING 75; PLATE,FIXATION,BONE

Model Number 422.396

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: hwc jds.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on an unknown date, during a procedure, the orthopedic plate and screws back out or were broken/failed.The patient was revived with another plate.The initial orif occurred on (b)(6) 2021.It was discovered on (b)(6) 2021, that the hardware had detached from the patient's femur.No broken fragments were left in the patient.There was a surgical delay.The surgery was successfully completed.The patient was recovering successfully.This complaint involves ten (10) devices.This report is for (1) 5.0 ti locking screw self-drilling 75.This report is 7 of 8 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6- the complaint condition was not confirmed for the 5.0 ti locking screw self-drilling 75 (p/n: 422.396 & lot #: 80p1095).During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is propose device history lot = as per jde, the manufactured date for device is 16-dec-2020.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure 100673626 no manufacturing record evaluation is required.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.0 TI LOCKING SCREW SELF-DRILLING 75
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12281117
• MDR Text Key: 265177537
• Report Number: 2939274-2021-04502
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982215901
• UDI-Public: (01)10886982215901
• Combination Product (y/n): N
• PMA/PMN Number: K963325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 422.396
• Device Catalogue Number: 422.396
• Device Lot Number: 80P1095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Date Manufacturer Received: 08/19/2021
• Patient Sequence Number: 1
• Treatment: TI LCP(TM) DSTL FEMUR PL 11 HOLES/276-RT; TI LCP(TM) DSTL FEMUR PL 11 HOLES/276-RT
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 123